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CTRI Number  CTRI/2025/06/088499 [Registered on: 10/06/2025] Trial Registered Prospectively
Last Modified On: 10/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to Check For Effectiveness Of Nasya treatment in the management of Anovulation Condition In PCOD 
Scientific Title of Study   A Randomised Clinical Trial To Evaluate The Efficacy Of Shigru Beejadi Ghruta And M D Forte Taila Nasya In The Management Of Anovulation In Polycystic Ovarian Disease PCOD 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pawar Sankirna Appu 
Designation  PG scholar 
Affiliation  Alvas Ayurveda Medical College,Moodbidrie 
Address  Alvas Ayurveda Medical College,Vidyagiri , Moodbidrie Department of Prasuti Tantra and stree roga OPD, Ground floor

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9148185776  
Fax    
Email  sankiran.pawar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Asokan V 
Designation  Professor 
Affiliation  Alvas Ayurveda Medical College,Moodbidrie 
Address  Alvas Ayurveda Medical College,Vidyagiri , Moodbidrie Department of Prasuti Tantra and Stree Roga

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9148185776  
Fax    
Email  drasokan24@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pawar Sankirna Appu 
Designation  PG scholar 
Affiliation  Alvas Ayurveda Medical College,Moodbidrie 
Address  Alvas Ayurveda Medical College,Vidyagiri , Moodbidrie Department of Prasuti Tantra and Stree Roga OPD, ground floor

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9148185776  
Fax    
Email  sankiran.pawar@gmail.com  
 
Source of Monetary or Material Support  
Alvas ayurveda Medical College and hospital,Moodbidrie, Vidyagiri 574227 D.K (karnataka) 
 
Primary Sponsor  
Name  Dr Pawar Sankirna Appu 
Address  Alvas Ayurveda Medical College, Moodbidrie,Vidyagiri 574227 D.K (karnataka)  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sankirna pawar  Alvas ayurveda Medical College and hospital   Alvas ayurveda Medical College and hospital,Vidyagiri,Moodbidri Department of Prasuti Tantra and Stree Roga OPD Ground floor
Dakshina Kannada
KARNATAKA 		 9148185776

Sankiran.pawar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC , Alvas Ayurveda Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Charak samhita, Procedure details: Pratimarsha nasya with shigru beejadi ghruta of 2 bindu (1ml) will be instilled in each nostril for 10 days after day 5 of menses for 3 consecutive months)
(1) Medicine Name: Shigru beejadi ghruta, Reference: Self made formulation, Route: Nasal, Dosage Form: Ghrita, Dose: 2(ml), Frequency: od, Duration: 3 Months
2Comparator ArmProcedure-nasyam, नस्यम् (Procedure Reference: Charak samhita, Procedure details: Pratimarsha nasya either with oil or ghruta will be instilled 2 bindus (1ml) in each nostril for 10 days after day 5 of menses for 3 consecutive cycles)
(1) Medicine Name: MD Forte taila, Reference: Amrutkala pharmacy, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(ml), Frequency: od, Duration: 3 Months
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Married women
2.Irregular menses
3.Hyperandrogenism
4.Polycystic ovaries 
 
ExclusionCriteria 
Details  1. Patients with primary amenorrhea.
2. Endocrinological disorders like Diabetes Mellitus, Thyroid abnormalities, Congenital Adrenal Hyperplasia and Hyperprolactinemia.
3. Chronic systemic diseases which can interfere with the treatment.
4. Any malignancy of Breast or cervical or ovarian origin.
5.Patients on oral contraceptive pills, IUCD, injectable contraceptives.
6. USG showing Congenital or Acquired Anatomical defects, Pelvic pathology.
7.Pregnant and lactating mothers.
8.Those contraindicated for Pratimarsha Nasya.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Assesed based on subjective and objective parameters

Subjective Parameters
Quantity of menses
2.Duration of bleeding
3.Interval between the menstrual cycles
4.Pain during menses

Objective parameters
1.Hirsutism score
2.GAGS score scale
3.ANSC scoring chart
4.BMI and Weight Reduction, and WHR.
5.Vas Score
6.WaLIDD score
7.USG of pelvis for ovarian follicular study, endometrial thickness and to assess ovulation BT once and at the end of the study (3rd M).
 		 Follicular study will be done for 3 months to check ovulation
and final assessment will be done on 3rd month of study 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   26/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [Sankiran.pawar@gmail.com].

  6. For how long will this data be available start date provided 09-06-2025 and end date provided 23-03-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NL
Brief Summary   Polycystic ovarian syndrome is a common gynecological condition that affects women of reproductive age with its increasing incidence due to sedentary lifestyle, excess intake of junk food and stress.
                 Incidence of 8-13% in women of reproductive age and upto 70% of cases are undiagnosed1. Anovulation is the cause of infertility in about a third of couples attending infertility clinics and PCOS accounts for 90% of such cases
                  Women with PCOS have irregular menstrual cycle, androgen excess, insulin resistance, anovulation, hirsutism, acne and infertility.
Modern management of PCOS is targeted to weight reduction in obese, hormonal pills and invasive techniques, which gives only symptomatic relief.
We find these symptoms of PCOS in Ayurveda as Pushpaghni Jataharini, Artavakshaya, Nastartava and Granthibhuta Artava 
In this study, polycystic ovarian disease (PCOD) will be considered as main emphasis will be given on treatment for ovulation and other symptoms of PCOS will not be included.
Shigru Beejadi Ghruta will be formed by combination of Shigru Beeja, Jatamamsi, Trikatu and Nagakesara.This combination of drugs may be proven beneficial in providing relief to multiple symptoms present in PCOS
                    Mundi Dhanyaka Taila which is currently available as M.D Forte Taila from Amruthakala Ayurveda  is proved to be beneficial in treating anovulation and other symptoms of PCOS.
 
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